small molecule

WAKIX

PITOLISANT HYDROCHLORIDE

Loss of exclusivityFebruary 2033FDA regulatory exclusivity expiry

CompanyHARMONY BIOSCIENCES MANAGEMENT INC

Drug detail

Brand name	WAKIX
Active ingredient	PITOLISANT HYDROCHLORIDE
Strength	EQ 17.8MG BASE
Dosage form	TABLET
Route	ORAL
Modality	Small molecule
FDA approval	August 2019
Marketing status	RX

Listed patents

Patent	Expires	Type
8207197	March 2030	substance, product
8486947	September 2029	use U-1102
8354430	February 2026	use U-1102

Regulatory exclusivity

Code	Expires
ODE-519	February 2033
ODE-489	June 2031
ODE-331	October 2027
NPP	June 2027
ODE-255	August 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.

Drug detail

Listed patents

Regulatory exclusivity

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